PV-Tracker™ ABFBF-003V
GUDID 10816349014861
Lake Region Medical
Peripheral vascular guidewire, manual| Primary Device ID | 10816349014861 |
| NIH Device Record Key | 7b35ae3a-6054-4e1c-ab49-66bebdbe7061 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PV-Tracker™ |
| Version Model Number | 990045 |
| Catalog Number | ABFBF-003V |
| Company DUNS | 031108704 |
| Company Name | Lake Region Medical |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Guidewire Length | 200 Centimeter |
| Guidewire Diameter | 0.32 Inch |
| Guidewire Length | 200 Centimeter |
| Guidewire Diameter | 0.32 Inch |
| Guidewire Length | 200 Centimeter |
| Guidewire Diameter | 0.32 Inch |
| Guidewire Length | 200 Centimeter |
| Guidewire Diameter | 0.32 Inch |
| Guidewire Length | 200 Centimeter |
| Guidewire Diameter | 0.32 Inch |
| Guidewire Length | 200 Centimeter |
| Guidewire Diameter | 0.32 Inch |
| Guidewire Length | 200 Centimeter |
| Guidewire Diameter | 0.32 Inch |
| Guidewire Length | 200 Centimeter |
| Guidewire Diameter | 0.32 Inch |
| Guidewire Length | 200 Centimeter |
| Guidewire Diameter | 0.32 Inch |
| Guidewire Length | 200 Centimeter |
| Guidewire Diameter | 0.32 Inch |
| Guidewire Length | 200 Centimeter |
| Guidewire Diameter | 0.32 Inch |
| Guidewire Length | 200 Centimeter |
| Guidewire Diameter | 0.32 Inch |
| Guidewire Length | 200 Centimeter |
| Guidewire Diameter | 0.32 Inch |
| Guidewire Length | 200 Centimeter |
| Guidewire Diameter | 0.32 Inch |
| Guidewire Length | 200 Centimeter |
| Guidewire Diameter | 0.32 Inch |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, KEep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, KEep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, KEep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, KEep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, KEep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, KEep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, KEep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, KEep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, KEep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, KEep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, KEep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, KEep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, KEep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, KEep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, KEep away from sunlight |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816349014864 [Primary] |
| GS1 | 10816349014861 [Package] Contains: 00816349014864 Package: [5 Units] In Commercial Distribution |
FDA Product Code
| DQX | Wire, Guide, Catheter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-20 |
| Device Publish Date | 2025-02-12 |
Devices Manufactured by Lake Region Medical
| 10816349014861 - PV-Tracker™ | 2025-02-20 |
| 10816349014861 - PV-Tracker™ | 2025-02-20 |
| 08714729761761 - ZIPwire™ | 2024-06-28 |
| 08714729761778 - ZIPwire™ | 2024-06-28 |
| 08714729761785 - ZIPwire™ | 2024-06-28 |
| 08714729761792 - ZIPwire™ | 2024-06-28 |
| 08714729761808 - ZIPwire™ | 2024-06-28 |
| 08714729755333 - ZIPwire™ | 2024-06-28 |
| 08714729755326 - ZIPwire™ | 2024-06-28 |
Trademark Results [PV-Tracker]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PV-TRACKER 77191159 not registered Dead/Abandoned |
Ablation Frontiers, Inc. 2007-05-26 |
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